EARLY: Educational Intervention to Improve Patient Awareness on Early LDL-C Lowering in Secondary… (NCT07252388) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
EARLY: Educational Intervention to Improve Patient Awareness on Early LDL-C Lowering in Secondary Prevention
Italy240 participantsStarted 2025-12-11
Plain-language summary
Cluster Randomized Trial to test the effectiveness of a patient level delivered educational intervention to improve the awareness on the relevance of obtaining LDL cholesterol recommended goals in patients admitted for an acute coronary syndrome, as compared to usual care. Overall, 24 sites (Coronary Care Units) will be included in the study, 12 randomized to the intervention and 12 to usual care. Overall, 240 patients will be enrolled during an acute coronary syndrome hospitalization.
Who can participate
Age range18 Years – 79 Years
SexALL
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Inclusion criteria
✓. Age ≥18 and \<80 years old.
✓. Males and females at birth.
✓. Baseline LDL-Cholesterol:
✓. Discharged at home
✓. Ability to understand the requirements of the study and to provide informed consent
Exclusion criteria
✕. Patients who have previously received or currently treated with PCSK9i (evolocumab or alirocumab) or siRNA (inclisiran)
✕. Unstable clinical status (hemodynamic or electrical instability)
✕. Uncontrolled cardiac arrhythmias, defined as recurrent, symptomatic ventricular tachycardia or atrial fibrillation or flutter with rapid ventricular response
✕. Severe renal dysfunction, defined by eGFR \< 30 mL/min/1.73 m2
✕. Active liver disease or liver dysfunction, reported in the medical record or defined by AST or ALT levels \> 3 times the upper limit of normal.
✕. Reported intolerance to statins defined by the following criteria: inability to tolerate at least two different statins; intolerance associated with confirmed and intolerable statin-related adverse effects or significant biomarker abnormalities; improvement/resolution of symptoms or biomarkers following dose decrease or discontinuation; symptoms or changes in biomarkers not attributable to established predispositions.
What they're measuring
1
Number of patients achieving Guideline recommended LDL-Cholesterol goal